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SPC you later to drug-device combinations

Thursday 10 January 2019

On 25 October 2018 the Court of Justice of the European Union (CJEU) handed down its judgment on the case C-527/17 relating to supplementary protection certificates (SPCs) for drug-device combination products. In brief, the CJEU decided that the drug-device combination product in question was not eligible for an SPC. This article considers the background and implications of the judgment.

What are SPCs for?

Obtaining a marketing authorisation (MA) for a medicinal product in a Member State of the European Union (EU) is a lengthy process and the MA may be granted many years after a patent for the medicinal product is applied for. Since a granted patent gives the owner market exclusivity for an invention for a fixed period of time (in Europe, the patent term is 20 years from the filing date of the patent application), the period of time during which a patented product cannot be sold by anyone is effectively wasted. To mitigate the negative effects of such patent “down time”, it is possible to obtain a supplementary protection certificate (SPC) in Member States to extend the term of a patent by up to 5 years.

SPCs may be granted for medicinal products which have an MA in accordance with one of two Directives of the European Parliament: Directive 2001/83/EC relating to medicinal products for human use and Directive 2001/82/EC relating to veterinary medicinal products. MAs for medical devices are granted under a different Directive (Directive 93/42/EEC as amended by Directive 2007/47/EC), and as such SPCs are not ordinarily available for medical devices. However, it is not always clear whether products which combine a medical device with a medicinal product (such as a drug) are eligible for SPCs and until now there have been conflicting court decisions regarding the issue.

Background of the case

C-527/17 was referred to the CJEU by the German Federal Patents Court regarding an SPC application filed by Boston Scientific on the basis of a patent relating to the use of Paclitaxel (a well-known anticancer drug) to reduce restenosis, and on the basis of an MA for a coronary stent coated with Paclitaxel (TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System).

The SPC application had originally been filed with the German Patent Office, but had been rejected on the ground that the product forming the subject of the SPC application did not have the type of MA required for an SPC application. Boston Scientific had then appealed before the German Federal Patents Court, arguing that Paclitaxel already had an MA in accordance with Directive 2001/83, and that the authority carrying out the authorisation of the TAXUS medical device under Directive 93/42 had assessed the safety and usefulness of Paclitaxel in the device in a manner equivalent to the MA procedure under Directive 2001/83.

Breakdown of the judgment

The CJEU first established that the terms ‘medicinal product’ and ‘medical device’ are mutually exclusive, and that in order to determine whether a product falls under one of the terms, the principle mode of action of the product should be taken into account. In particular, the CJEU stated that a product which achieves its principle intended action in the human body by pharmacological, immunological or metabolic means is classified as a medicinal product, whereas a product which does not achieve its principle intended action in this way is classified as a medical device.

In this regard, the CJEU considered that the action of the Paclitaxel in the TAXUS medical device was merely ancillary to the principle mode of action of the device, and could not be classified as a medicinal product independent of the device. Therefore, the principle mode of action of the TAXUS medical device was that of a stent, even though Paclitaxel formed an integral part of the device.

Furthermore, the CJEU argued that the MA procedure under Directive 93/42 for medical devices comprising a medicinal substance is not equivalent or comparable to the MA procedure under Directive 2001/83 for medicinal products. The court’s reasoning was that under Directive 93/42 the usefulness, quality and safety of ancillary substance are assessed by taking into account the intended use of the medical device and the way the substance is included in the device, but not by assessing the substance for use as an independent medicinal product in accordance with Directive 2001/83. In addition, the court stated that according to the Regulation governing SPCs for medicinal products, SPCs are intended to protect medicinal products and not medical devices and substances used as an adjuvant of a medical device.

Therefore, the CJEU ruled that an MA procedure under Directive 93/42 for a medical device cannot be treated in the same way as an MA procedure under Directive 2001/83 for the purpose of obtaining an SPC.

Conclusion

The CJEU’s judgment confirms that SPCs are not available for drug-device combination products where main mode of action is that of the device. Although this may be disappointing for patent-holders seeking to extend protection for this type of product, it will still be possible to obtain SPCs based on MAs for the medicinal product itself.

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